The Federal Circuit granted en banc review of the scope of on-sale bar under 35 USC 102(b). Medicines Co. v. Hospira, Inc., No. 2014-1469. In this case, laboratory services were provided to the patent owner to reduce impurities in material covered by product-by-process claims. The Federal Circuit panel held that on-sale bar may apply where only services are provided and title does not change hands. The en banc court has presented the following questions: (a) do the circumstances presented here constitute a commercial sale under the on-sale bar of 35 USC 102(b)? (i) was there a sale for the purposes of 102(b) despite the absence of a transfer of title? (ii) was the sale commercial in nature for the purposes of 102(b) or an experimental use? (b) should this court overrule or revise the principle in Special Devices, Inc. v. OEA, Inc., 270 F.3d 1353 (Fed. Cir. 2001), that there is no "supplier exception" to the on-sale bar of 35 USC 102(b)?
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On Nov. 11, 2015, the Federal Circuit in a 2-1 decision held that that the USITC does not have jurisdiction under Section 337 to exclude electronic transmissions of digital data as they are not considered as "articles." ClearCorrect scans physical models of patient's teeth, creates a digital recreation of initial tooth arrangement, and transmits the digital recreation to its subsidiary outside. The foreign subsidiary creates digital data models of intermediate tooth positions and transmits it back to ClearCorrect. Align Technology alleged that ClearCorrect violated Section 337 by practicing its claimed methods abroad and importing the electronic data set to the U.S. The commission granted an exclusion order finding that ClearCorrect's data transmissions were "articles." In reversing the Commission's ruling, the Federal Circuit concluded that ITC lacked jurisdiction to exclude importation of electronic transmissions as the statutory language and congressional intent make clear that the jurisdiction is limited to "articles" that are material things and do not extend to digital transmissions. Full text of the opinion is available here.
In a 2-1 decision,the Federal Circuit held that a product is not "made by" a patented process for the purposes of infringement under 35 USC 271(g) if it is merely used to determine whether the intended product of a separately-patented process has been manufactured. Momenta Pharm. Inc. v. Teva Pharm. USA, Inc., No. 2014-1274 (Fed. Cir. Nov. 10, 2015). The court held that the routine use of a patented testing process in the commercial manufacture of a drug is not covered by 35 USC 271(e) safe harbor provision. In this case, Momenta, assignee of asserted patent, markets generic version of an anticoagulant Enoxaparin. Teva sources the generic version from Italian company Chemi S.p.A. that manufactures, analyzes, tests, packages and labels Teva's generic version which Teva imports into the U.S. Momenta sued Teva for infringement of its patented process. The court concluded that Teva's products were not "made by" Momenta's patented process for purposes of 271(g). Full text of the opinion is available here.
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